MHRA paediatric investigation plan
Not yet available in the United Kingdom (Daybu proposed in the EEA and currently being assessed) (Trofinetide)
MHRA paediatric investigation plan MHRA-101573-PIP01-24 · Agreement
Key facts
| PIP number | MHRA-101573-PIP01-24 |
|---|---|
| Product names | Not yet available in the United Kingdom (Daybu proposed in the EEA and currently being assessed), Daybue |
| Active substances | Trofinetide |
| Therapeutic areas | Neurology |
| Conditions | Treatment of Rett syndrome |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Jan 6, 2025 |
| MHRA record | cms.mhra.gov.uk |
About MHRA paediatric investigation plans
A paediatric investigation plan sets out the studies a company must run in children to support authorisation of a medicine in the UK, or records a waiver or deferral.
Source: UK Medicines and Healthcare products Regulatory Agency (MHRA). Contains public sector information licensed under the Open Government Licence v3.0 · Source date: